Slide 1: Intraocular Pressure Outcomes With Intravitreal Aflibercept 8 mg and 2 mg in DME: PHOTON
Intraocular Pressure Outcomes With Intravitreal Injection of Aflibercept 8 mg and 2 mg in Patients With Diabetic Macular Edema Through Week 48 of the Phase 2/3 PHOTON Trial Diana V. Do, MD,’ on behalf of the PHOTON study investigators Byers Eye Institute, Stanford University School of Medicine, Palo
Slide 2: Disclosures
Disclosures ¢ Dr. Do is a consultant to Boehringer Ingelheim, Genentech, Kodiak Sciences, Kriya, and Regeneron Pharmaceuticals, Inc.; has received research funding from Boehringer Ingelheim, Genentech, Kriya, and Regeneron Pharmaceuticals, Inc.; and has stock options from Kodiak Sciences « This stud
Slide 3: Background
Background DME + Aflibercept 8 mg demonstrated non-inferior visual outcomes compared to aflibercept 2 mg with fewer injections at Week 48 in patients with DME from the PHOTON trial’ * As aflibercept 8 mg is administered in a 70-uL injection volume versus a 50-uL injection volume for aflibercept 2 mg
Slide 4: PHOTON Study Design
PHOTON Study Design Multi-center, randomized, double-masked study in patients with DME? Randomized 1 (2q8) : 2 (8q12) : 1 (8q16) 2q8 Aflibercept 2 mg every 8 weeks after 5 initial monthly injections (50 pL) n=167 Fellow eyes could receive aflibercept 2 mg at the discretion of the investigator Primar
Slide 5: Glaucoma-related History at Baseline
Glaucoma-related History at Baseline Study Eye Fellow Eye? 2q8 | 8q12 | 8qi6 2q8 | 8q12 | 8q16 (n=167) | (n=328) |(n=163)| | (n=167) | (n=328) |(n=163) Eyes with medical history of glaucoma/ glaucoma suspect AND/OR Receiving 21 IOP-lowering agent® at baseline, n (%) The proportions of eyes with glau
Slide 6: Methods: IOP Assessment in the PHOTON Trial
Methods IOP Assessment in the PHOTON Trial * Bilateral IOP was measured at all study visits; the same method of measurement was used in each patient throughout the study? — On days when study drug was administered, sites were permitted to follow their usual post-injection monitoring routine. The stu
Slide 7: Mean Pre-dose IOP Values in Study and Fellow Eyes Were Similar
Mean Pre-dose IOP Values in Study and Fellow Eyes Were Similar Through Week 48 Study Eye Fellow Eye (Treated and Untreated) #298 (n=167) -+8q12 (n=328) —A-8q16 (n=163) #-2q8 (n=167) -M#+-8q12 (n=328) —-8q16 (n=163) Mean IOP, mmHg Mean IOP, mmHg 8 12 16 20 24 28 32 36 40 44 48 16 20 24 28 32 36 40 44
Slide 8: Mean Pre-dose IOP Values in Study and Untreated Fellow Eyes Were Similar
Mean Pre-dose IOP Values in Study and Untreated Fellow Eyes Were Similar Through Week 48 Study Eye Fellow Eye (Untreated) 298 (n=167) i 8q12 (n=328) —*-8q16 (n=163) = nN al 3 Mean IOP, mmHg 3 12 16 20 24 28 32 36 40 44 48 Week Mean IOP, mmHg —0-2q8 (n=64) -M+8q12 (n=128) —*&-8q16 (n=62) 12 16 20 24
Slide 9: Change in Pre-dose IOP Values in Study and Fellow Eyes Were Similar
Change in Pre-dose IOP Values in Study and Fellow Eyes Were Similar Through Week 48 Study Eye Fellow Eye (Treated? and Untreated) —0-2q8 (n=167) -@-8q12 (n=328) —*-8q16 (n=163) in pre-dose IOP, mmHg Co Mean change from baseline oa ° 4 8 12 16 20 24 28 32 36 40 44 48 Week e298 (n=167) —-8q12 (n=328)
Slide 10: Change in Pre-dose IOP Values in Study and Untreated Fellow Eyes Were Similar
Change in Pre-dose IOP Values in Study and Untreated Fellow Eyes Were Similar Through Week 48 Study Eye Fellow Eye (Untreated) #-2q8 (n=167) -M+8q12 (n=328) —a-8q16 (n=163) to ° Mean change from baseline in pre-dose IOP, mmHg 20 24 28 32 36 40 44 48 Week Mean change from baseline in pre-dose lOP, mm
Slide 11: Cumulative Incidence of Eyes Meeting Pre-dose IOP Analysis Criteria
Cumulative Incidence of Eyes Meeting Pre-dose IOP Analysis Criteria Through Week 48 Study Eye Fellow Eye? 2q8 | 8q12 |) Bqi6 2q8 | 8q12 | 8q16 (n=167) | (n=328) |(n=163)|™ (n=167) | (n=328) | (n=163) Pre-dose IOP increase of 25 mmHg from baseline at 2 consecutive visits Pre-dose IOP 225 mmHg at 2 co
Slide 12: IOP Through Week 48 in the Study Eye
IOP Through Week 48 in the Study Eye 2q8 8q12 8q16 All 8 mg (n=167) | (n=328) |(n=t63)5) (n=491) IOP 235 mmHg pre- or post-injection at any visit, n (%)
Slide 13: Mean Change in Pre-dose to Post-dose IOP in Study Eyes
Mean Change in Pre-dose to Post-dose IOP in Study Eyes at Active Dosing Visits ° o & o D f= o i 3S a @ fF G o = pre- to post-dose IOP, mmHg 2q8 8q12 8q16 All 8 mg (n=2145) (n=2810) (n=1218) (n=4028) Mean change from pre- to post-dose IOP was similar across treatment groups Safety analysis set: 2q8n=
Slide 14: IOP-lowering Medications in Eyes Without Glaucoma-related History
IOP-lowering Medications in Eyes Without Glaucoma-related History Through Week 48 Study Eye Fellow Eye? 2q8 | 8q12 | 8q16 2q8 | 8q12 | 8q16 (n=167) |(n=328) |(n=463)| (n=167) | (n=328) |(n=163) Eyes with no glaucoma-related history, n (%)° Pa anf Eyes with no glaucoma-related history who were starte
Slide 15: IOP-lowering Medications in Eyes Without Glaucoma-related History
IOP-lowering Medications in Eyes Without Glaucoma-related History Through Week 48 Study Eye Fellow Eye? 2q8 8q12 | 8q16 2q8 8q12 | 8q16 (n=167) |(n=328) |(n=163) [i (n=167) |(n=328) |(n=163) Eyes with no glaucoma-related history, n (%)° a aff Eyes with no glaucoma-related history who were started on
Slide 16: IOP-lowering Medications in Eyes Without Glaucoma-related History
IOP-lowering Medications in Eyes Without Glaucoma-related History Through Week 48 Study Eye Fellow Eye? 2q8 8q12 | 8q16 2q8 8q12 | 8q16 (n=167) |(n=328) |(n=163) [i (n=167) |(n=328) |(n=163) Eyes with no glaucoma-related history, n (%)° a aff Eyes with no glaucoma-related history who were started on
Slide 17: IOP-lowering Procedures in All Patients
1IOP-lowering Procedures? in All Patients Through Week 48 Study Eye Fellow Eye? 2q8 | 8q12 | 8q16 2q8 | 8q12 | 8q16 (n=167) | (n=328) |(n=163)| | (n=167) | (n=328) |(n=163) Eyes receiving anterior chamber paracentesis with or without an l|OP-lowering agent? through Week 48, n (%) « Anterior chamber
Slide 18: Conclusions
Conclusions DME In patients with DME, pre-dose IOP values in the study eye were similar through Week 48 across treatment groups Pre-dose IOP values were similar through Week 48 between study eyes and fellow eyes (treated and untreated with aflibercept 2 mg) No clinically relevant differences in chan